What Martin Shkreli And Donald Trump Have In Common: Chagas Edition

I’ll cut right to the chase, here: It is time for our 44th President to exercise some (more) of his constitutional executive power, and direct FDA to disallow “plainly abusive” priority review voucher requests.

There is little doubt that the FDA, pursuant to its orderly administration initiatives (and especially if acting on Executive Branch direct order) could deny (or at least delay until it had handled more worthy projects), under Section 524(a)(3) of the FD&C Act, any application it deemed to be plainly abusive of the system — diverting scarce resources from more worthy FDA endeavors, for example. So — one solution set approach here could be to tell Mr. Shkreli that FDA will review his Chagas/benznidazole request, after all current pending requests have been completed — and granted — for novel treatments. This would put his date for a transferable voucher — in the cue, somewhere into the year 2020. And his investors plainly won’t want to wait that long. Ahhh. . . Poof! — goes one Martin Shkreli. [Backgrounder. In passing, I’ll note that I was honored to have worked with and for one of the scientists who helped bring an earlier version Chagas treatment to market — long before all this gamesmanship became commonplace.]

I’ll not dwell at length on Mr. Shkreli’s latest antics (read up on them, there — if you haven’t already) — other than to note that he and Mr. Trump are two of the “neediest” rich guys on the planet. They both have a pathological, insatiable hunger for constant 24/7/365 attention — even negative attention. Mr. Shkreli now has a large stake in the foundering KaloBios Pharma, with which company he has acquired the rights to one form of benznidazole, an as yet US FDA unapproved treatment for Chagas disease.

. . . .Mr. Shkreli estimated that 3,000 to 7,000 people would require treatment for acute infection each year in the United States.

But many specialists say that is wildly unrealistic because there are few cases of acute disease in the United States and they are rarely detected.

“I don’t see him having a market at all,” said Dr. Robert H. Gilman, professor of international health at Johns Hopkins University. “At the current rate of diagnosis, I don’t see it.”

Susan Montgomery, who runs the program at the disease control centers that provides benznidazole, said there have been only seven acute cases caused by the kissing bug and detected in the United States since 1955. She said that over all the centers provide 60 to 70 courses of treatment a year of benznidazole or nifurtimox, another Chagas drug. . . .

Seven cases — for which Mr. Shkreli would seek an FDA voucher worth somewhere between $125 million and $450 million, to some other anxious pharma or bio-science buyer. And, to cap it all off — he claims he’d charge over $60,000 for a US course of benznidazole, the Chagas treatment — a drug that sells for $50 to $100 for a two month treatment course just a stone’s throw south of our borders. Yes — he and Mr. Trump are needy. The fix for Shkreli is to have the FDA, by rule, disallow his abuse of the voucher program — and teach his minion investors a lesson, in public policy. Onward — on a warm and sunny Saturday!